* These values are not included in the computation
of the cumulative reduction of virus since the virus clearance is within
the variability limit of the assay ( ≤ 1.0).
NA Not Applicable. Solvent/detergent treatment does not affect non-lipid
enveloped viruses.
NT Not Tested.

When reconstituted with the total volume of diluent (Sterile Water for Injection,
USP) supplied, this preparation contains approximately 50 mg of protein per
mL (5%), of which at least 90% is gamma globulin. The product, reconstituted
to 5%, contains a physiological concentration of sodium chloride (approximately
8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components
are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin
(Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG),
1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL
polysorbate 80. If it is necessary to prepare a 10% (100 mg/mL) solution for
infusion, half the volume of diluent should be added, as described in the DOSAGE
AND ADMINISTRATION. In this case, the stabilizing agents and other components
will be present at double the concentrations given for the 5% solution. The
manufacturing process for GAMMAGARD S/D (immune globulin) , isolates IgG without additional chemical
or enzymatic modification, and the Fc portion is maintained intact. GAMMAGARD (immune globulin)
S/D contains all of the IgG antibody activities which are present in the donor
population. On the average, the distribution of IgG subclasses present in this
product is similar to that in normal plasma.3

INDICATIONS

GAMMAGARD S/D (immune globulin) is not indicated in patients with selective IgA deficiency where
the IgA deficiency is the only abnormality of concern (see WARNINGS).

Primary Immunodeficiency Diseases

GAMMAGARD S/D (immune globulin) is indicated for the treatment of primary immunodeficient states,
such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich
syndrome, and severe combined immunodeficiencies.6,7 This indication
was supported by a clinical trial of 17 patients with primary immunodeficiency
who received a total of 341 infusions. GAMMAGARD S/D (immune globulin) is especially useful when
high levels or rapid elevation of circulating IgG are desired or when intramuscular
injections are contraindicated (e.g., small muscle mass).

B-cell Chronic Lymphocytic Leukemia (CLL)

GAMMAGARD S/D (immune globulin) is indicated for prevention of bacterial infections in patients
with hypogammaglobulinemia and/or recurrent bacterial infections associated
with B-cell Chronic Lymphocytic Leukemia (CLL). In a study of 81 patients, 41
of whom were treated with GAMMAGARD, Immune Globulin Intravenous (Human), bacterial
infections were significantly reduced in the treatment group.8,9
In this study, the placebo group had approximately twice as many bacterial infections
as the IGIV group. The median time to first bacterial infection for the IGIV
group was greater than 365 days. By contrast, the time to first bacterial infection
in the placebo group was 192 days. The number of viral and fungal infections,
which were for the most part minor, was not statistically different between
the two groups.

Idiopathic Thrombocytopenic Purpura (ITP)

When a rapid rise in platelet count is needed to prevent and/or to control
bleeding in a patient with Idiopathic Thrombocytopenic Purpura, the administration
of GAMMAGARD S/D (immune globulin) , should be considered.

The rise in platelet count to greater than 40,000/mm3 occurred after
a single 1 g/kg infusion of GAMMAGARD (immune globulin) in 8 patients with chronic ITP (6 adults,
2 children), and in 2 patients with acute ITP (one adult, one child). A similar
response was observed after two 1 g/kg infusions in 3 adult patients with chronic
ITP, and one child with acute ITP. The remaining 2 adult patients with chronic
ITP received more than two 1 g/kg infusions before achieving a platelet count
greater than 40,000/mm3. The rise in platelet count was generally rapid, occurring
within 5 days. However, this rise was transient and not considered curative.
Platelet count rises lasted 2 to 3 weeks, with a range of 12 days to 6 months.
It should be noted that childhood ITP may resolve spontaneously without treatment.

Kawasaki Syndrome

GAMMAGARD S/D (immune globulin) , is indicated for the prevention of coronary artery aneurysms
associated with Kawasaki syndrome. The percentage incidence of coronary artery
aneurysm in patients with Kawasaki syndrome receiving GAMMAGARD (immune globulin) either at a
single dose of 1 g/kg (n=22) or at a dose of 400 mg/kg for four consecutive
days (n=22), beginning within seven days of onset of fever, was 3/44 (6.8%).
This was significantly different (p=0.008) from a comparable group of patients
that received aspirin only in previous trials and of whom 42/185 (22.7%) experienced
coronary artery aneurysms.10,11,12 All patients in the GAMMAGARD (immune globulin)
trial received concomitant aspirin therapy and none experienced hypersensitivity-type
reactions (urticaria, bronchospasm or generalized anaphylaxis).13
Several studies have documented the efficacy of intravenous gammaglobulin in
reducing the incidence of coronary artery abnormalities resulting from Kawasaki
syndrome.10-12, 14-17

DOSAGE AND ADMINISTRATION

Primary Immunodeficiency Diseases

For patients with primary immunodeficiencies, monthly doses of approximately
300-600 mg/kg infused at 3 to 4 week intervals are commonly used.42,43
As there are significant differences in the half-life of IgG among patients
with primary immunodeficiency, the frequency and amount of immunoglobulin therapy
may vary from patient to patient. The proper amount can be determined by monitoring
clinical response. The minimum serum concentration of IgG necessary for protection
varies among patients and has not been established by controlled clinical trials

B-cell Chronic Lymphocytic Leukemia (CLL)

For patients with hypogammaglobulinemia and/or recurrent bacterial infections due to B-cell Chronic Lymphocytic Leukemia, a dose of 400 mg/kg every 3 to 4 weeks is recommended.

Kawasaki Syndrome

For patients with Kawasaki syndrome, either a single 1 g/kg dose or a dose
of 400 mg/kg for four consecutive days beginning within seven days of the onset
of fever, administered concomitantly with appropriate aspirin therapy (80-100
mg/kg/day in four divided doses) is recommended.44

Idiopathic Thrombocytopenic Purpura (ITP)

For patients with acute or chronic Idiopathic Thrombocytopenic Purpura, a dose
of 1 g/kg is recommended. The need for additional doses can be determined by
clinical response and platelet count. Up to three separate doses may be given
on alternate days if required.

No prospective data are presently available to identify a maximum safe dose,
concentration, and rate of infusion in patients determined to be at increased
risk of acute renal failure. In the absence of prospective data, the recommended
doses should not be exceeded and the concentration and infusion rate selected
should be the minimum level practicable. Reduction in dose, concentration, and/or
rate of administration in patients at risk of acute renal failure has been proposed
in the literature in order to reduce the risk of acute renal failure.45

Reconstitution: Use Aseptic Technique

When reconstitution is performed aseptically outside of a sterile laminar air flow hood, administration should begin as soon as possible, but not more than 2 hours after reconstitution. When reconstitution is performed aseptically in a sterile laminar air flow hood, the reconstituted product may be either maintained in the original glass container or pooled into VIAFLEX bags and stored under constant refrigeration (2-8°C), for up to 24 hours. (The date and time of reconstitution/pooling should be recorded). If these conditions are not met, sterility of the reconstituted product cannot be maintained. Partially used vials should be discarded.

5. Remove protective covering from the spike at one end of the transfer device
(Fig. 1)

6. Place the diluent bottle on a flat surface and, while holding the bottle to prevent slipping, insert the spike of the transfer device perpendicularly through the center of the bottle stopper.

7. Press down firmly so that the transfer device fits snugly against the diluent bottle (Fig. 2).

Caution: Failure to use center of stopper may result in dislodging the
stopper.

8. Remove the protective covering from the other end of the transfer device. Hold diluent bottle to prevent slipping.

9. Hold concentrate bottle firmly and at an angle of approximately 45 degrees. Invert the diluent bottle with the transfer device at an angle complementary to the concentrate bottle (approximately 45 degrees) and firmly insert the transfer device into the concentrate bottle through the center of the rubber stopper (Fig. 3).

Note: Invert the diluent bottle with attached transfer device rapidly into
the concentrate bottle in order to avoid loss of diluent.

Caution: Failure to use center of stopper may result in dislodging the
stopper and loss of vacuum.

10. The diluent will flow into the concentrate bottle quickly. When diluent
transfer is complete, remove empty diluent bottle and transfer device from concentrate
bottle. Discard transfer device after single use. 11. Thoroughly wet the dried
material by tilting or inverting and gently rotating the bottle (Fig. 4). Do
not shake. Avoid foaming.

12. Repeat gentle rotation as long as undissolved product is observed.

B. 10% Solution

Follow steps 1-4 as previously described in A.

5. To prepare a 10% solution, reconstitute with the appropriate volume of diluent as indicated in Table 2, which indicates the volume of diluent required for a 5% or 10% concentration. Using aseptic technique, draw the required volume of diluent into a sterile hypodermic syringe and needle. Discard the filled syringe.

6. Using the residual diluent in the diluent vial, follow steps 5-12 as previously
described in A

Table 2: Required Diluent Volume

Concentration

2.5 g bottle

5 g bottle

10 g bottle

5%

50 mL

96 mL

192 mL

10%

25 mL

48 mL

96 mL

Rate of Administration

It is recommended that initially a 5% solution be infused at a rate of 0.5
mL/kg/Hr. If infusion at this rate and concentration causes the patient no distress,
the administration rate may be gradually increased to a maximum rate of 4 mL/kg/Hr
for patients with no history of adverse reactions to IGIV and no significant
risk factors for renal dysfunction or thrombotic complications. Patients who
tolerate the 5% concentration at 4 mL/kg/Hr can be infused with the 10% concentration
starting at 0.5 mL/kg/Hr. If no adverse effects occur, the rate can be increased
gradually up to a maximum of 8 mL/kg/Hr. In general, it is recommended that
patients beginning therapy with IGIV or switching from one IGIV product to another
be started at the lower rates of infusion and should be advanced to the maximal
rate only after they have tolerated several infusions at intermediate rates
of infusion. It is important to individualize rates for each patient. As noted
in the WARNINGSsection, patients who
have underlying renal disease or who are judged to be at risk of developing
thrombotic events should not be infused rapidly with any IGIV product.

Although there are no prospective studies demonstrating that any concentration
or rate of infusion is completely safe, it is believed that risk may be decreased
at lower rates of infusion.45 Therefore, as a guideline, it is recommended
that these patients who are judged to be at risk of renal dysfunction or thrombotic
complications be gradually titrated up to a more conservative maximal rate of
less than 3.3 mg/ kg/min ( < 2mL/kg/Hr of a 10% solution or < 4mL/kg/Hr
of a 5% solution).

It is recommended that antecubital veins be used especially for 10% solutions,
if possible. This may reduce the likelihood of the patient experiencing discomfort
at the infusion site (see ADVERSE REACTIONS).

A rate of administration which is too rapid may cause flushing and changes in pulse rate and blood pressure. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.

Drug Interactions

Admixtures of GAMMAGARD S/D, Immune Globulin Intravenous (Human), with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMMAGARD S/D (immune globulin) be administered separately from other drugs or medications which the patient may be receiving. The product should not be mixed with Immune Globulin Intravenous (Human) from other manufacturers. Antibodies in immune globulin preparations may interfere with patient responses to live vaccines, such as those for measles, mumps, and rubella. The immunizing physician should be informed of recent therapy with Immune Globulin Intravenous (Human) so that appropriate precautions can be taken.

Administration

GAMMAGARD S/D (immune globulin) should be administered as soon after reconstitution as possible,
or as described in the DOSAGE AND ADMINISTRATION.

The reconstituted material should be at room temperature during administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Reconstituted material should be a clear to slightly opalescent and colorless
to pale yellow solution. Do not use if particulate matter and/or discoloration
is observed.

Follow directions for use which accompany the administration set provided.
If another administration set is used, ensure that the set contains a similar
filter.

HOW SUPPLIED

GAMMAGARD S/D (immune globulin) is supplied in 2.5 g (NDC number 0944-2620-02), 5 g (NDC number 0944-2620-03), or 10 g (NDC number 0944-2620-04) single use bottles. Each bottle of GAMMAGARD S/D (immune globulin) is furnished with a suitable volume of Sterile Water for Injection, USP, a transfer device and an administration set which contains an integral airway and a 15 micron filter.

Storage

GAMMAGARD S/D (immune globulin) is to be stored at a temperature not to exceed 25°C (77°F). Freezing should be avoided to prevent the diluent bottle from breaking.

SIDE EFFECTS

Increases in creatinine and blood urea nitrogen (BUN) have been observed as
soon as one to two days following infusion. Progression to oliguria and anuria
requiring dialysis has been observed, although some patients have improved spontaneously
following cessation of treatment.35

Types of severe renal adverse reactions that have been seen following IGIV
therapy include:

In general, reported adverse reactions to GAMMAGARD (immune globulin) , in patients with either
congenital or acquired immunodeficiencies are similar in kind and frequency.
Various minor reactions, such as mild to moderate hypotension, headache, fatigue,
chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight
elevation of blood pressure, nausea and vomiting may occasionally occur. Slowing
or stopping the infusion usually allows the symptoms to disappear promptly.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility.
Epinephrine and antihistamines should be available for treatment of any acute
anaphylactoid reaction (See WARNINGS).

Primary Immunodeficiency Diseases

Twenty-one adverse reactions occurred in 341 infusions (6%), when using GAMMAGARD (immune globulin)
(5% solution), in a clinical trial of 17 patients with primary immunodeficiency.40
Of the 17 patients, 12 (71%) were adults, and 5 (29%) were children (16 years
or younger).

In a cross-over study comparing GAMMAGARD and GAMMAGARD S/D (immune globulin) (5% solutions) conducted in a small number (n=10) of primary immunodeficient patients, no unusual or unexpected adverse reactions were observed in the GAMMAGARD S/D (immune globulin) group. The adverse reactions experienced in the GAMMAGARD S/D (immune globulin) group were similar in frequency and nature to those observed in the control group consisting of patients receiving GAMMAGARD (immune globulin) .

GAMMAGARD (immune globulin) , reconstituted to a concentration of 10%, was administered intravenously
at rates varying from 2 to 11 mL/kg/Hr. Systemic reactions occurred in 23 (10.5%)
of 219 infusions. This compares with an adverse reaction incidence of 6% (only
systemic reactions reported) for primary immunodeficient patients previously
treated with a 5% solution at infusion rates varying between 2 and 8 mL/kg/Hr,
as described above (see reference 40). Local pain or irritation was experienced
during 35 (16%) of 219 infusions. Application of a warm compress to the infusion
site alleviated local symptoms. These local reactions tended to be associated
with hand vein infusions and their incidence may be reduced by infusions via
the antecubital vein.

B-cell Chronic Lymphocytic Leukemia (CLL)

In the study of patients with B-cell Chronic Lymphocytic Leukemia, the incidence
of adverse reactions associated with GAMMAGARD (immune globulin) infusions was approximately 1.3%
while that associated with placebo (normal saline) infusions was 0.6%.9

Idiopathic Thrombocytopenic Purpura (ITP)

During the clinical study of GAMMAGARD (immune globulin) for the treatment of Idiopathic Thrombocytopenic Purpura, the only adverse reaction reported was headache which occurred in 12 of 16 patients (75%). Of these 12 patients, 11 had chronic ITP (9 adults, 2 children), and one child had acute ITP. Oral antihistamines and analgesics alleviated the symptoms and were used as pretreatment for those patients requiring additional IGIV therapy. The remaining 4 patients did not report any side effects and did not require pretreatment.

Kawasaki Syndrome

In a study of patients (n=51) with Kawasaki syndrome, no hypersensitivity-type
reactions (urticaria, bronchospasm or generalized anaphylaxis) were reported
in patients receiving either a single 1g/kg dose of IGIV, GAMMAGARD (immune globulin) , or 400
mg/kg of IGIV, GAMMAGARD (immune globulin) , for four consecutive days.13 Mild adverse
reactions, including chills, flushing, cramping, headache, hypotension, nausea,
rash and wheezing, were reported with both dose regimens. These adverse reactions
occurred in 7/51 (13.7%) patients and in association with 7/129 (5.4%) infusions.
Of the 25 patients who received a single 1 g/kg dose, 4 patients experienced
adverse reactions for an incidence of 16%. Of the 26 patients who received 400
mg/kg/day over 4 days, 3 experienced a single adverse reaction for an incidence
of 11.5%.3

Postmarketing

The following list of adverse reaction have been identified and reported during
the post-approval use of IGIV products:

Because postmarketing reporting of these reactions is voluntary and the at-risk
populations are of uncertain size, it is not always possible to reliably estimate
the frequency of the reaction or establish a causal relationship to exposure
to the product. Such is also the case with literature reports authored independently.41
(See PRECAUTIONS)

WARNINGS

Warning

Immune Globulin Intravenous (Human) products have been reported to be associated
with renal dysfunction, acute renal failure, osmotic nephrosis, and death.18
Patients predisposed to acute renal failure include patients with any degree
of pre-existing renal insufficiency, diabetes mellitus, age greater than 65,
volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic
drugs. Especially in such patients, IGIV products should be administered at
the minimum concentration available and the minimum rate of infusion practicable.
While these reports of renal dysfunction and acute renal failure have been associated
with the use of many of the licensed IGIV products, those containing sucrose
as a stabilizer accounted for a disproportionate share of the total number.*

See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections for important
information intended to reduce the risk of acute renal failure.

*GAMMAGARD S/D (immune globulin) does not contain sucrose.

GAMMAGARD S/D, Immune Globulin Intravenous (Human) is made from human plasma.
Products made from human plasma may contain infectious agents, such as viruses,
that can cause disease. The risk that such products will transmit an infectious
agent has been reduced by screening plasma donors for prior exposure to certain
viruses, by testing for the presence of certain current virus infections, and
by inactivating and/or removing certain viruses (See DESCRIPTION).
Despite these measures, such products can still potentially transmit disease.
Because this product is made from human blood, it may carry a risk of transmitting
infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease
(CJD) agent. ALL infections thought by a physician possibly to have been transmitted
by this product should be reported by the physician or other healthcare provider
to Baxter Healthcare Corporation at 1-800-423-2862 (in the U.S.). The physician
should discuss the risks and benefits of this product with the patient.

GAMMAGARD S/D, Immune Globulin Intravenous (Human), should only be administered intravenously. Other routes of administration have not been evaluated.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine and antihistamines should be available for treatment of any acute anaphylactoid reactions.

GAMMAGARD S/D (immune globulin) contains only trace amounts of IgA ( ≤ 2.2 µg/mL in a
5% solution). GAMMAGARD S/D (immune globulin) is not indicated in patients with selective IgA
deficiency where the IgA deficiency is the only abnormality of concern. It should
be given with caution to patients with antibodies to IgA or IgA deficiencies,
that are a component of an underlying primary immunodeficiency disease for which
IGIV therapy is indicated.7,19 In such instances, a risk of anaphylaxis
may exist despite the fact that GAMMAGARD S/D (immune globulin) contains only trace amounts of
IgA.

PRECAUTIONS

General

Some viruses, such as B19V (formerly known as parvovirus B19) or hepatitis
A, are particularly difficult to remove or inactivate at this time. B19V most
seriously affects pregnant women, or immune-compromised individuals. Symptoms
of B19V infection include fever, drowsiness, chills, and runny nose followed
about two weeks later by a rash and joint pain. Evidence of hepatitis A may
include several days to weeks of poor appetite, tiredness, and low-grade fever
followed by nausea, vomiting, and abdominal pain. Dark urine and a yellowed
complexion are also common symptoms. Patients should be encouraged to consult
their physician if such symptoms appear.

An aseptic meningitis syndrome (AMS) has been reported to occur infrequently
in association with Immune Globulin Intravenous (Human) [IGIV] treatment. Discontinuation
of IGIV treatment has resulted in remission of AMS within several days without
sequelae. The syndrome usually begins within several hours to two days following
IGIV treatment. It is characterized by symptoms and signs including severe headache,
nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and
nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive
with pleocytosis up to several thousand cells per mm3, predominantly
from the granulocytic series, and elevated protein levels up to several hundred
mg/dL. Patients exhibiting such symptoms and signs should receive a thorough
neurological examination, including CSF studies, to rule out other causes of
meningitis. AMS may occur more frequently in association with high dose (2 g/kg)
IGIV treatment.

Periodic monitoring of renal function tests and urine output is particularly
important in patients judged to have a potential increased risk for developing
acute renal failure. Assure that patients are not volume depleted prior to the
initiation of the infusion of IGIV. Renal function, including measurement of
blood urea nitrogen (BUN)/serum creatinine, should be assessed prior to the
initial infusion of GAMMAGARD S/D (immune globulin) and again at appropriate intervals thereafter.
If renal function deteriorates, discontinuation of the product should be considered.

For patients judged to be at risk for developing renal dysfunction, it may be prudent to reduce the rate of infusion to less than 4 mL/kg/Hr ( < 3.3 mg IG/kg/min) for a 5% solution or at a rate less than 2 mL/kg/ Hr ( < 3.3 mg IG/kg/min) for a 10 % solution.

Certain components used in the packaging of this product contain natural rubber latex.

Transfusion-Related Acute Lung Injury (TRALI)

There have been reports of noncardiogenic pulmonary edema (Transfusion Related
Acute Lung Injury [TRALI]) in patients administered IGIV.24 TRALI
is characterized by severe respiratory distress, pulmonary edema, hypoxemia,
normal left ventricular function, and fever and typically occurs within 1 to
6 hours after transfusion. Patients with TRALI may be managed using oxygen therapy
with adequate ventilatory support.

IGIV recipients should be monitored for pulmonary adverse reactions. If TRALI
is suspected, appropriate tests should be performed for the presence of anti-neutrophil
antibodies in both the product and patient serum (See PRECAUTIONS: Laboratory
Tests).

Thrombotic Events

Thrombotic events have been reported in association with IGIV25-33
(See ADVERSE REACTIONS). Patients at risk may include those with a history
of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired
cardiac output, and/or known or suspected hyperviscosity, hypercoaguable disorders
and prolonged periods of immobilization. The potential risks and benefits of
IGIV should be weighed against those of alternative therapies for all patients
for whom IGIV administration is being considered. Baseline assessment of blood
viscosity should be considered in patients at risk for hyperviscosity, including
those with cryoglobulins, fasting chylomicronemia/markedly high triacylgycerols
(triglycerides), or monoclonal gammopathies (See PRECAUTIONS: Laboratory
Tests). Analysis of adverse event reports13,34 has indicated
that a rapid rate of infusion may be a risk factor for vascular occlusive events.

Laboratory Tests

If signs and/or symptoms of hemolysis are present after IGIV infusion, appropriate
confirmatory laboratory testing should be done (see PRECAUTIONS).

If TRALI is suspected, appropriate tests should be performed for the presence
of anti-neutrophil antibodies in both the product and patient serum (see PRECAUTIONS).

Because of the potentially increased risk of thrombosis, baseline assessment
of blood viscosity should be considered in patients at risk for hyperviscosity,
including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols
(triglycerides), or monoclonal gammopathies (see PRECAUTIONS).

Pregnancy Category C

Animal reproduction studies have not been conducted with GAMMAGARD S/D, Immune Globulin Intravenous (Human). It is also not known whether GAMMAGARD S/D (immune globulin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. GAMMAGARD S/D (immune globulin) should be given to a pregnant woman only if clearly needed.

OVERDOSE

No information provided.

CONTRAINDICATIONS

GAMMAGARD S/D (immune globulin) is contraindicated in patients with selective IgA deficiency
where the IgA deficiency is the only abnormality of concern (see INDICATIONS and WARNINGS). Patients may experience
severe hypersensitivity reactions or anaphylaxis in the setting of detectable
IgA levels following infusion of GAMMAGARD S/D (immune globulin) . The occurrence of severe hypersensitivity
reactions or anaphylaxis under such conditions should prompt consideration of
an alternative therapy.

CLINICAL PHARMACOLOGY

GAMMAGARD S/D, Immune Globulin Intravenous (Human), contains a broad spectrum
of IgG antibodies against bacterial and viral agents that are capable of opsonization
and neutralization of microbes and toxins.

Peak levels of IgG are reached immediately after infusion of GAMMAGARD S/D (immune globulin) .
It has been shown that, after infusion, exogenous IgG is distributed relatively
rapidly between plasma and extravascular fluid until approximately half is partitioned
in the extravascular space. Therefore, a rapid initial drop in serum IgG levels
is to be expected.4 As a class, IgG survives longer in vivo
than other serum proteins.4,5 Studies show that the half-life of
GAMMAGARD S/D (immune globulin) is approximately 37.7 ± 15 days.3 Previous studies
reported IgG half-life values of 21 to 25 days.4,5 using radiolabeled IgG or
17.7 to 37.6 days measuring IgG levels during administration of IGIV to immunodeficient
patients.6 The half-life of IgG can vary considerably from person
to person, however. In particular, high concentrations of IgG and hypermetabolism
associated with fever and infection have been seen to coincide with a shortened
half-life of IgG. 4-7